Hybrid Cochlear Implants in Severe to Profound Adults, Children, and Adolescents

Inclusion Criteria

1.1 Criteria for Inclusion in Population 1

Criterion for selection will be subject interest in preservation of residual hearing; severe sensorineural hearing loss; lack of benefit from appropriately fit binaural hearing aids worn on a full-time basis; and realistic expectations. Qualified participants must also meet the following criteria for inclusion:

• Eighteen year of age or older at the time of implantation.
• Severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies in the ear to be implanted.
• Speech Perception:
• The Consonant-Nucleus-Consonant (CNC) word recognition score between 0% and 35% inclusive in the ear to be implanted.
• The CNC word recognition score in the contralateral ear equal to or better than, in the ear to be implanted but not more than 60% in the best-aided condition.
• English spoken as a primary language.
• Willingness to comply with all study requirements.
• Minimum of 30 day hearing aid trial with appropriately fit hearing aids worn on a full-time basis (8 hours per day).
• Patent cochlea and normal cochlear anatomy.

1.2 Criteria for Inclusion in Population 2

Criterion for selection will be parent interest in preservation of residual hearing; severe post-lingual onset of sensorineural hearing loss; lack of benefit from appropriately fit binaural hearing aids worn on a full-time basis; and supportive family dynamics. Qualified participants must also meet the following criteria for inclusion:

• Five to fifteen years of age at the time of implantation.
• Severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies in the ear to be implanted.
• Speech Perception:
• The Phonetically Balanced-Kindergarten (PB-K) word recognition score between 0% and 50% inclusive in the ear to be implanted.
• The PB-K word recognition score in the contralateral ear equal to or better than, in the ear to be implanted but not more than 60%.
• English spoken as a primary language.
• Willingness to comply with all study requirements.
• Minimum of 30-day hearing aid trial with appropriately fit hearing aids worn on a full-time basis (8 hours per day)..
• Patent cochlea and normal cochlear anatomy.
• Must be in a habilitation/educational program with an emphasis on spoken language development.

Exclusion Criteria

1.3 Criteria for Exclusion in Populations 1 and 2

• Medical or psychological conditions that contraindicate undergoing surgery.
• Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
• Unrealistic expectations on the part of the candidate and/or candidate's family, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices.
• Unwillingness or inability of the candidate to comply with all investigational requirements.
• Active middle ear infection.